BD Vacutainer Urine Complete Cup KitRecalls & reported problems across all models

We found 2 models of BD Vacutainer Urine Complete Cup Kit by Becton, Dickinson And Company in the FDA's device registry (GUDID). Together they are named in 43 adverse event reports in the FDA's MAUDE database, received between Dec 1, 2017 and May 21, 2026 — classified as 6 injuries, 37 malfunctions.

The most frequently reported specific device problem is “Short Fill” (9 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

BD Vacutainer Urine Complete Cup Kit recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. May 25, 2022Open, Classified

   Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

   Z-1617-2022 · Root cause: Environmental control · Recall details · FDA record ↗

Most reported BD Vacutainer Urine Complete Cup Kit problems

BD Vacutainer Urine Complete Cup Kit models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• BD Vacutainer® Urine Complete Cup Kit 364957

  SYSTEM, TRANSPORT, AEROBIC
  1 recall5 reports
• BD Vacutainer® Urine Complete Cup Kit 364956

  CULTURE MEDIA, NON-PROPAGATING TRANSPORT
  38 reports

Recent BD Vacutainer Urine Complete Cup Kit adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2026Short Fill

  IT WAS REPORTED WHILE USING BD VACUTAINER® URINE COMPLETE CUP KIT, THE TUBES IN THE KIT WERE NOT DRAWING URINE INTO TUBES WITH GOOD VACUUM. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25249513 ↗
• MalfunctionDec 1, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED WHILE USING ONE BD VACUTAINER® URINE COMPLETE CUP KIT, 1 PATIENT REPORTED THE TOWELETTE WAS DISCOLORED AND IS CONCERNED THAT IT WAS CONTAMINATED. THERE WAS NO OTHER HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23688041 ↗
• MalfunctionNov 10, 2025Microbial Contamination of Device; Device Ingredient or Reagent Problem; Microbial Contamination of Device; Device Ingredient or Reagent Problem

  IT WAS REPORTED DURING USE OF BD VACUTAINER® URINE COMPLETE CUP KIT, 15 TUBES ARE CONTAMINATED. THEY ARE SEEING MIXED GROWTH IN CULTURES. IN ADDITION, THE ADDITIVE LOOKS LIKE CONDENSATION. SAMPLES WERE RECOLLECTED. THERE WAS NO OTHER HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23511632 ↗
• MalfunctionSep 16, 2025Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® URINE COMPLETE CUP KIT, THE SOAP TOWELETTES IN 20 KITS WERE DRY. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23067227 ↗
• MalfunctionAug 6, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED WHILE USING BD VACUTAINER® URINE COMPLETE CUP KIT, AN UNSPECIFIED NUMBER OF KITS CONTAIN TOWELETTES WHICH BREAK APART EASILY AND ARE DIFFICULT TO CLEANSE PROPERLY. CUSTOMER HAS REPORTED AN INCREASE IN CONTAMINATED URINE SAMPLES. THERE WAS NO OTHER HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22731383 ↗
• MalfunctionJul 15, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED BEFORE USING THE BD VACUTAINER® URINE COMPLETE CUP KIT THERE WAS UNKNOWN FOREIGN MATTER INSIDE ONE DEVICE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22512110 ↗
• MalfunctionJun 2, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® URINE COMPLETE CUP KIT THERE WAS SAMPLE LEAKAGE ON 5 DEVICES EVEN WHEN THE LID WAS SECURE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22127002 ↗
• MalfunctionApr 25, 2025Off-Label Use; Short Fill; Expiration Date Error; Off-Label Use; Short Fill; Expiration Date Error

  IT WAS REPORTED WHILE USING BD VACUTAINER® URINE COMPLETE CUP KIT, UNDERFILL WAS OBSERVED IN AN UNSPECIFIED NUMBER OF DEVICES. IT WAS THEN DISCOVERED THAT THE EXPIRATION DATE ON THE SHELF LABEL WAS BEYOND THE EXPIRATION DATE OF THE TUBE. THE EXPIRATION DATE ON THE TUBE LABEL HAD ALREADY PASSED SO EXPIRED TUBES WERE USED. THERE WERE NO HEALTH CONSEQUENCES OR IMPACTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21913518 ↗
• MalfunctionApr 22, 2025Off-Label Use; Short Fill; Inaccurate Information; Off-Label Use; Short Fill; Inaccurate Information

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® URINE COMPLETE CUP KIT THERE WAS SHORT FILL IN AN UNSPECIFIED NUMBER OF DEVICES. IT WAS THEN DISCOVERED THAT THE EXPIRATION DATE ON THE SHELF LABEL WAS BEYOND THE EXPIRATION DATE OF THE TUBE. THE EXPIRATION DATE ON THE TUBE LABEL HAD ALREADY PASSED SO AN EXPIRED TUBE WAS USED. THERE WERE NO HEALTH CONSEQUENCES OR IMPACTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21883472 ↗
• MalfunctionMar 31, 2025Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED WHILE USING BD VACUTAINER® URINE COMPLETE CUP KIT, TWO (2) TUBES UNDERFILLED AND LOST SUCTION AFTER 1ML. SAMPLE WAS REDRAWN. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21734313 ↗
• MalfunctionFeb 13, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT PRIOR TO USING BD VACUTAINER® URINE COMPLETE CUP KIT, AN UNSPECIFIED NUMBER OF KITS HAD OPEN AND DRY TOWELETTES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21378886 ↗
• MalfunctionJan 10, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED PRIOR TO USING BD VACUTAINER® URINE COMPLETE CUP KIT THAT ONE HUNDRED AND TWENTY-THREE KITS (123) HAD OPEN AND DRY TOWELETTES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21129904 ↗
• MalfunctionJan 2, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED PRIOR TO USING BD VACUTAINER® URINE COMPLETE CUP KIT THAT EIGHTY-SIX (86) KITS HAD OPEN AND DRY SOAP TOWELETTES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21064029 ↗
• MalfunctionJul 3, 2024Short Fill; Device Ingredient or Reagent Problem; Short Fill; Device Ingredient or Reagent Problem

  IT WAS REPORTED WHILE USING BD VACUTAINER® URINE COMPLETE CUP KIT AN UNSPECIFIED NUMBER OF TUBES HAD SIGNIFICANT CONDENSATION AND DID NOT FILL COMPLETELY. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19670238 ↗
• InjuryMay 7, 2024Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED WHILE USING THE BD VACUTAINER® URINE COMPLETE CUP KIT THAT THE NEEDLE REMAINED IN THE VACUTAINER TUBE WHEN THE SAMPLE WAS REMOVED FROM THE URINE COLLECTION CUP. A HEALTHCARE WORKER RECEIVED A MINOR ABRASION ON THEIR THUMB WHEN HANDLING THE VACUTAINER TUBE. POST EXPOSURE BLOOD WORK WAS OBTAINED AND TESTED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN AN EMPLOYEE WENT TO REMOVE THE VACUTAINER TUBE FROM THE URINE COLLECTION CUP LID NEEDLE, THE NEEDLE CAME OUT OF THE LID. CUSTOMER WASN'T EXPECTING THE NEEDLE TO BE ON TOP OF A TUBE, AND WENT TO PUT THE TUBE DOWN WHICH RESULTED IN A MINOR ABRASION ON HER THUMB. IF EXPOSURE OCCURRED WAS THERE ANY POST EXPOSURE TESTING OR MEDICAL INTERVENTION? YES, THE BLOODWORK IS UNDERWAY, AND THE PATIENT INFORMATION AND RESULTS ARE AVAILABLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19262394 ↗

Other Becton, Dickinson And Company products

• BD Vacutainer SST10 models · 4,985 reports · 3 recalls
• BD Luer-Lok48 models · 5,117 reports
• BD Insyte Autoguard33 models · 4,465 reports · 8 recalls
• BD SafetyGlide17 models · 2,185 reports
• BD Vacutainer Eclipse Blood Collection Needle4 models · 1,880 reports
• BD Vacutainer Push Button Blood Collection Set9 models · 1,831 reports
• BD Nexiva25 models · 1,614 reports · 1 recall
• BD BACTEC MGIT Mycobacteria Growth Indicator Tubes2 models · 1,554 reports